The Alpha-Stim 100 combines microcurrent (MET) & cranial electrotherapy stimulator (CES) for pain, anxiety, depression, insomnia and stress.

Alpha-Stim devices require a prescription from a licensed health care or mental health professional. You can use this Form to obtain an Alpha-Stim device.

Alpha-Stim Product Features		Alpha-Stim 100 For treating multiple pain areas, and the axiety, insomnia and depression often associated with chronic pain		Alpha-Stim SCS For treating anxiety, insomnia and depression without pain		Alpha-Stim PPM For treating simple pain problems on one or two areas of the body, without attendant anxiety, insomnia and depression
Primary Indications
Pain		X				X
Anxiety		X		X
Insomnia		X		X
Depression		X		X
Treatment Methods
Probes for Pain		X
Electrodes for Pain		X				X
Ear Clips for CES		X		X
Five (5) Year Warranty		X		X		X
Access to clinical and technical support		X		X		X

Treating Pain with MET

The Alpha-Stim 100 uses microcurrent electrical therapy (MET) for those suffering from acute, chronic or postoperative pain.

The Alpha-Stim 100 works with the body on a large variety of ailments, including difficult-to-treat problems. Alpha-Stim 100 microcurrent technology produces residual and cumulative results, far superior to previous traditional milliampere transcutaneous electrical nerve stimulation (TENS) devices. Turn a TENS off and the pain returns. Although broadly classified as a TENS, the Alpha-Stim 100 is significantly superior because MET works with tiny currents, closer to the type and amount of electricity that naturally occurs in the body. By comparison, the electric current used by typical TENS devices is thousands of times greater than natural body current. Although a slight tingling sensation is sometimes felt under the electrodes, it is not necessary to feel this in order to achieve results.

Many people feel nothing at all with the Alpha-Stim 100 except positive results. MET is applied through easy to use probes or self-adhesive electrodes. Specific treatment protocols are included with the Alpha-Stim 100 and technical assistance is readily available by telephone, fax, e-mail or mail. Alpha-Stim technology is backed by more independent research than any other device in its class. Electromedical Products International, Inc. has been in business since 1981, treating a wide variety of medical disorders with Alpha-Stim microcurrent technology during that time with no reports of significant side effects.

The billing code E0730(TENS code) can be used for treating pain only below the shoulders. Other insurance billing codes can be found here.

Treating anxiety, depression, and/or insomnia with CES

The Alpha-Stim 100 treats anxiety, depression, and/or insomnia with microcurrent using a method called cranial electrotherapy stimulation (CES). The treatment is very simple. The current is applied by easy to use clip electrodes that attach on the ear lobes. Used just 20 to 40 minutes every day, every other day, or on an as-needed basis, it can help induce a pleasant, relaxed feeling of well being. The Alpha-Stim 100 is well tolerated and very safe in contrast to drugs used in the treatment of mood disorders, many of which have been proven to have undesirable side effects and can be addictive. Unlike drugs, the Alpha-Stim 100 leaves the mind alert. Anxiety reduction is usually experienced during treatment. Depression and insomnia control is generally experienced after one to two weeks of daily treatment. CES can also help treat the underlying mood disorders associated with pain.

It may be used as an adjunct to medication and/or psychotherapy. After treatment, there are usually no physical limitations imposed so the majority of people can resume normal activities immediately. Maintenance of a relaxed, yet alert state is generally achieved with treatments three times per week. As a result, the Alpha-Stim 100 is suitable for clinical or home use.

Prescribing Information

Caution statement for United States:

Federal Law (U.S.A. only) restricts this device to sale by, or on the order of a LICENSED HEALTH CARE PRACTITIONER. Outside of the U.S.A. it is available world wide without a prescription but consultation with a qualified health care professional is recommended for difficult and unresponsive problems or when used in conjunction with pharmaceuticals or other therapeutic intervention.

For possible insurance reimbursement: Insurance reimbursement for your Alpha-Stim varies widely and mainly depends upon your insurance policy and carrier. Many plans that cover durable medical equipment will pay for the Alpha-Stim. Call us at 800-521-4640 or email sales@bio-medical.com for more information on insurance reimbursement.

Indications:

Alpha-Stim 100 cranial electrotherapy stimulation (CES) technology is continuously being subjected to rigorous study and evaluation by the international medical community. Findings to date indicate that the Alpha-Stim 100 is an effective treatment with broad applications for a variety of syndromes involving pain, and for the management of anxiety, depression, and/or insomnia, or for the short term relief of the symptoms of pain, anxiety, depression and/or insomnia. In many cases it is the sole therapeutic method required. Effective results in pain management have been seen during and/or subsequent to stimulation over affected body parts, adjacent areas, and areas distant from those in pain. As with any therapeutic intervention, not all people will respond to the Alpha-Stim 100. The degree of efficacy will vary with the nature of the problem being treated, the overall health of the person, and with the method of treatment.

Contraindications:

The Alpha-Stim 100 may effect the operation of cardiac pacemakers (particularly demand type pacemakers). Do not stimulate directly on the eyes, or over the carotid sinus (on the neck beside the larynx).

Precautions:

For external use only. Do not allow children to use or handle this device without adult supervision. Do not operate potentially dangerous machinery or vehicles during, and in some cases, for several hours after treatment. Caution is advised in cases where other forms of analgesia (pain control) would not be used; such as to retain the beneficial aspects of pain for diagnosis or in cases where people may overuse pain-controlled areas. Safety of stimulation has not been established during pregnancy. There have been isolated reports of blood pressure being lowered by CES so care should be taken while using the Alpha-Stim 100 with high blood pressure medication.

Adverse Effects:

Adverse effects are usually mild and self-limiting. Adverse effects seen in approximately 4,541 patients in controlled, open, uncontrolled conditions, and by physician survey and reasonably associated with the use of CES are dizziness (6 cases, 0.13%), skin irritation/electrode burns (5 cases, 0.11%), and headaches (9 cases, 0.20%). Prolonged CES treatment at higher than necessary currents may cause dizziness or nausea that can last from hours to days. Treatment immediately prior to going to sleep may cause difficulty sleeping due to increased alertness. It is recommended that CES be used at least 3 hours before going to sleep. Paradoxical reactions such as hyperexcited states, increased anxiety, and sleep disturbances may occur.

Please be advised, this is considered a custom item. Returns will be accepted only within 30 days of original purchase and charged a 15% re-stocking fee.

• AS-Trode electrode pads - 4 pack
• Two 48" wires
• Two probes
• One set of CE-2B ear clip electrodes
• 200 felt electode pads
• 15 ml Alpha Conduction Solution
• One 9v battery
• Carrying case
• Illustrated Owner's manual

Warranty: Each Alpha-Stim 100 is warranted to be free from defects in materials and workmanship under normal use for a period of five years except for replacement of batteries and accessories. See Owners Manual for complete details.

The Alpha-Stim 100 is distinct in that it is based on the concept that the biophysics underlying the bodys biochemistry also plays a significant role in regulating all of lifes processes. Doctors are taught that there are about 75 trillion cells in a human body, each having an electrical potential across its cell membrane, similar to a battery. Alpha-Stims proprietary waveform works by moving electrons through the body and brain at a variety of frequencies, collectively known as harmonic resonance. This normalizes the electrical activity of the nervous system and brain as measured by an electroencephalogram (EEG).

How does Alpha-Stim cranial electrotherapy stimulation (CES) technology work? The exact mechanism by which Alpha-Stim technology produces effects is not fully known. However, based on previous and ongoing studies, it appears that the Alpha-Stim microcurrent waveform activates particular groups of nerve cells that are located at the brainstem. These groups of nerve cells produce the chemicals serotonin and acetylcholine which can affect the chemical activity of nerve cells that are both nearby and at more distant sites in the nervous system. In fact, these cells are situated to control the activity of nerve pathways that run up into the brain and that course down into the spinal cord. By changing the electrical and chemical activity of certain nerve cells in the brainstem, Alpha-Stim technology appears to amplify activity in some neurological systems, and diminish activity in others. This neurological ‘fine tuning’ is called modulation, and occurs either as a result of, or together with the production of a certain type of electrical activity pattern in the brain known as an alpha state which can be measured on brain wave recordings (called electro-encephalograms, abbreviated EEG). Such alpha rhythms are accompanied by feelings of calmness, relaxation and increased mental focus. The neurological mechanisms that are occurring during the alpha state appear to decrease stress-effects, reduce agitation and stabilize mood, and regulate both sensations and perceptions of particular types of pain.

These effects can be produced after a single treatment, and repeated treatments have been shown to increase the relative strength and duration of these effects. In some cases, effects have been stable and permanent, suggesting that the electrical and chemical changes evoked by Alpha-Stim technology have led to a durable re-tuning back to normal function. Electromedical Products International, Inc. is dedicated to continued research into the mechanisms and effects through which Alpha-Stim technology can be beneficial to patients with pain, anxiety, depression and sleep disorders.

Alpha-Stim CES engages the serotonergic (5-HT) raphe nuclei of the brainstem. 5-HT inhibits brainstem cholinergic (ACh) and noradrenergic (NE) systems that project supratentorially. This suppresses thalamo-cortical activity, arousal, agitation, alters sensory processing and induces EEG alpha rhythm. As well, 5-HT can act directly to modulate pain sensation in the dorsal horn of the spinal cord, and alter pain perception, cognition and emotionality within the limbic forebrain.

Legend:

• Blue arrows: inhibitory interactions
• Purple arrows: excitatory interactions
• X : suppressed pathways/interactions

Abbreviations: ACh: actetylcholine; LDT: laterodorsal tegmental nucleus of the brainstem; PPN: pediculo-ponitne nucleus of the brainstem; NE: norepinephrine; LC: locus ceruleus, 5-HT: serotonin

Note: Diagram not to scale

James Giordano, Ph.D. is a UNESCO Fellow and Scholar in Residence at the Center for Clinical Bioethics, Georgetown University Medical Center, Washington, DC. Dr. Giordano is also Visiting Scholar at the Center for Ethics, Dartmouth Medical School, Hanover, NH, and Invited Lecturer at the Roundtable in Arts and Sciences, Oxford University, UK. As a neuroscientist, Dr. Giordano's ongoing work is focused upon neural mechanisms of pain, the philosophy of pain research and practice of pain medicine, and the neuroethical issues inherent to the development and use of emergent technologies in neurology and psychiatry. Dr. Giordano received his Ph.D. in biological psychology from the City University of New York. He was a NIEHS post-doctoral fellow in neurotoxicology and neuroscience at The Johns Hopkins University, Baltimore, MD, served as Visiting Scientist in the Department of Clinical Neuropharmacology, Max Planck Institute for Psychiatry, Munich, Germany, was an American Psychological Association Visiting Fellow in neuroimaging at the Martinos Center for Advanced Imaging, Harvard University Medical School/Massachusetts General Hospital, and completed post-graduate training in bioethics at the Neiswanger Institute for Bioethics and Health Policy, Loyola University/Stritch Medical School, Chicago, IL. The author of over 65 refereed publications on pain, ethics and medical philosophy, Dr. Giordano serves as Neuroscience Section Editor for the Pain Physician journal, Bioethics Editor for the American Journal of Pain Management, and Ethics Section Editor for the journal Practical Pain Management.

• Power Source: One 9 volt battery (included). Replace with disposable batteries (alkaline preferred)
• Timer Settings: Probe (10 seconds on, alternating with 2 seconds off), 10, 20, 60 minutes, and continuous.
• Current: 10 to 600 A continuously adjustable.
• Frequency: 0.5, 1.5, or 100 Hz (pulses per second).
• Waveform: Bipolar asymmetric rectangular waves, 50% duty cycle, 0 net current.

The Alpha-Stim 100 is a class IIa, Type B medical device. It has been independently tested by outside agencies in order to provide assurance of conformity to applicable standards for medical equipment safety and electromagnetic compliance.

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Prescription Form

Alpha Stim Practitioners Guide

Insurance Billing for the Alpha-Stim

Alpha Stim 100 User Manual